Evaluation of uniplanar and biplanar valgus distal femoral osteotomy of patients with genovarum deformity
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 80 patients. Blocks of four will be used for randomization.
Settings and conduct
This study is a randomized clinical trial (blocks of four), double-blind (participants and results analyzer), with parallel groups, without a control group and with the participation of 80 patients with knee osteotomy surgery referred to Imam Reza Hospital (Tabriz).
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: age between 18 and 60 years, the complaint of limb deviation in the form of a leg brace (genovarum) and a candidate for osteotomy surgery, and the exclusion criteria also include: patients with a history of previous surgery on the knee, patients with a history of previous fractures Knee and grade 4 degenerative changes (Ahlbach classification) will be in the medial compartment.
Intervention groups
In this study, patients who will be referred to the operating room due to knee osteotomy surgery will undergo intervention. Patients will be randomly divided into two groups. Biplanar method will be performed for one group and uniplanar method will be performed for the other group, the results after surgery will be compared between the two groups.
Main outcome variables
Union
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N44
Registration date:2024-03-18, 1402/12/28
Registration timing:registered_while_recruiting
Last update:2024-03-18, 1402/12/28
Update count:0
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-18, 1402/12/28
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of uniplanar and biplanar valgus distal femoral osteotomy of patients with genovarum deformity
Public title
Osteotomy of the femur by two uniplanar and biplanar methods in patients with genovarum deformity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years
Complaint of limb deviation in the form of leg braces (genovarum)
Candidate for osteotomy surgery
Exclusion criteria:
Patients with a history of previous knee surgery
Patients with a history of previous knee fracture
Grade 4 degenerative changes (Ahlbach classification) in the medial compartment
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they will divid into two intervention groups (group A) and control group (group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of technique used, in this study they will not know what type of technique will be used in other patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2024-03-03, 1402/12/13
Ethics committee reference number
IR.TBZMED.REC.1402.928
Health conditions studied
1
Description of health condition studied
Union
ICD-10 code
M21.76
ICD-10 code description
Unequal limb length (acquired), tibia and fibula
Primary outcomes
1
Description
Union
Timepoint
Once every week for four weeks
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: atients will undergo surgery after being anesthetized. Surgery will be performed by a single surgeon; For this group, biplanar osteotomy will be performed and the level of infection will be evaluated for one month after surgery (once a week) in the form of a physical examination.
Category
Treatment - Surgery
2
Description
Intervention group: Patients will undergo surgery after being anesthetized. Surgery will be performed by a single surgeon; For this group, osteotomy will be performed using planar ion method and the level of infection will be evaluated for one month after surgery (once a week) in the form of physical examination.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Moradi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available